A kampo preparation is a pharmaceutical prepared by blending crude drugs, in which all the active ingredients are not always specifically identified. Furthermore, a single active ingredient alone does not always exhibit its effect, and some active ingredients may compositely act with each other. For securing its quality, it is said that an assay method capable of totally evaluating the whole kampo preparation is necessary (Patent Document 1, Patent Document 2).
The assay method includes a method of total evaluation by assaying the individual ingredients, and a bioassay method of evaluating the physiological activity by the use of a biological material. The bioassay includes an in-vivo test and an in-vitro test, and the in-vivo test system has many limitations regarding the test facilities, test animals, the processing capability, and the like, and there were some difficulties in applying the in-vivo test to quality evaluation of kampo preparations.
On the other hand, the in-vitro test system does not require any special facilities and gives stable test results in a short period of time. For this reason, it is desired to establish a bioassay method with this system. In fact, for myostatin, a bioassay method is reported (Patent Document 3). However, for a kampo preparation that comprises a combination of crude drugs each having plural active ingredients by themselves, a suitable bioassay system could not always be found out, and the establishment of the bioassay system is desired.
For example, yokukansan, a type of kampo preparation, generally is a crude drug mixture having the composition shown below, or is its extract, and as necessary, further contains a pharmaceutical carrier such as an excipient and other ingredients usable on a pharmaceutical preparation. However, a suitable bioassay system is not yet found out for yokukansan. For securing higher quality for yokukansan, the development of the bioassay system for yokukansan is desired.
TABLE 1IngredientsAmountJP Atractylodes Lancea Rhizome4.0 gJP Poria Sclerotium4.0 gJP Cnidium Rhizome3.0 gJP Japanese Angelica Root3.0 gJP Bupleurum Root2.0 gJP Glycryrrhiza1.5 gJP Uncaria Hook3.0 g    Patent Document 1: JP-T 2000-512621    Patent Document 2: JP-T 2001-521876    Patent Document 3: JP-T 2005-520486